pharm animal

It’s like a one, two punch… in the stomach.

The FDA approved a drug today that is used for people with a rare condition that creates fatal blood clots.  But, in doing so, they also approved the genetically altered goats that were used to make the drug, thereby opening the way for other companies to use GMO animals in pharmaceutical products.  

Proponents claim that this is a means of producing pharmaceuticals at a lower cost and will be reflected on the consumer price, that it is safe, and there is no way the animals can be released out of captivity.

However, opponents feel that “it is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures,” the Humane Society of the United States says in its position paper on the practice.

There are other concerns: that the animals could be harmed, that animal germs might contaminate the drug, that the milk or meat from genetically engineered drug-producing animals might enter the food supply or that the animals might escape and breed with others, spreading the gene, with unpredictable consequences.

In any case, they are now approved for use and time will tell if it is going to be harmful.  

* This was originally reported by the New York Times

genetically engineered approval

 

Last week, federal health officials announced plans for an approval process of genetically engineered (GE) animals used for food.  However, consumer groups say the plan is not enough to ensure the safety of the consumer, according to the Los Angeles Times.

Genetic engineering, already widely used for crops, is on the threshold of producing animals that can grow faster or even yield drugs that treat human illnesses. Although the potential benefits — and profits — are huge, many individuals have qualms about manipulating the genetic code of other living creatures.

The FDA has stated that it will not allow for the approval of GE animals without severe scrutiny.  But, many criticize the policy because, approving an GE animal, does not mean it will be labeled as such.  In other words, because of lack of labeling consumers, without knowing about or wanting to, may be ingesting GE animals.

There is also criticism that the evaluation of the animals does not include what might happen to the environment.  Of particular concern, is the possibility of am animal escaping and mating with a non-GE animal.

And, while many talk about the eating of GE animals, there is also debate from drugs made from GE animals.  Last week, a product made from the milk of a GE goat was before the FDA for approval.  At this point, it was deemed safe and effective for human use.  But, is it?

Many are urging the upcoming Obama administration to reconsider the current FDA policy on genetically engineered animals.  Although, the biotechnology industry welcomed the announcement from the FDA, and as we all know, the lobbying power of that group is strong in D.C.